When irbs still disagree: Challenges to conducting sexual health research with sexually-active adolescents, 2012-2013

Issues: Sexual health research with adolescents frequently involves several regulatory bodies for approval. Obtaining clearance is challenging when multiple institutional review board (IRBs) disagree on parental consent and study benefit. Description: We are conducting a study to develop and test an HIV/STI prevention and testing program for Black, heterosexually-active adolescents with mental health diagnoses (e.g., attention deficit disorders and depression). Preliminary work with this same demographic of at-risk youth suggested that a waiver of parental consent was appropriate to maintain participants' confidentiality, to facilitate enrollment, and to collect data to inform HIV prevention strategies. Lessons Learned: The protocol was reviewed by: 1) the academic institution IRB, and 2) local health department IRB; they disagreed on what constituted “minimal risk,” the appropriateness of the parental consent waiver, and possible liability due to a positive HIV/STI diagnosis. Guidance was sought from an objective local youth social justice legal entity; they determined that the proposed research was congruent with state laws and healthcare practices, and that proposed participants are capable of providing informed consent without parental permission. The protocol was approved after 11 months. Recommendations: This case highlights continued challenges faced in sexual health research with minors. It also underscores the importance of balancing IRB human subjects concerns with adolescent's legal rights to privacy and confidentiality. Sexual health researchers working with adolescents, particularly those considered 'vulnerable', should consider strategies to address these issues, ensure appropriate protections, and avoid protocol delays which may hinder goals to prevent new cases of HIV among at-risk youth.